Research and General Data Protection Regulations (GDPR)
Health and care research may be exploring prevention, diagnosis or treatment of disease, which includes health and social factors in any disease area.
All NHS organisations (including Health & Social Care in Northern Ireland) are expected to participate and support health and care research. The Health Research Authority (HRA) and government departments in Northern Ireland, Scotland and Wales set standards for NHS organisations to make sure they protect your privacy and comply with the law when they are involved in research. In addition, research ethics committees review research studies to make sure that the research uses of data about you are in the public interest, and meet ethical standards.
For information about how the Trust will collect and process your data for research purposes, plus the legal basis for collecting and using your information for research, please read here.
Managing Your Information - A Guide for Research Participants
The Health Research Authority has also produced guidance for the use of data for Research Purposes.
Information about Research Studies and Data
As an NHS organisation we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).
Our Data Protection Officer is Richard Green and you can contact them at dataprotectionofficer@nsft.nhs.uk
Research may be sponsored by companies developing new medicines or medical devices, NHS organisations, universities or medical research charities. The Research Sponsor (the Data Controller) decides what information will be collected for the study and how it will be used.
Below is a list of current (Either recruiting new participants or in follow-up) Research Studies for which Norfolk and Suffolk NHS Foundation Trust is the Research Sponsor and Data Controller (Please click on study names for link to the HRA web record).
| Name of Research Study | Title of study | Reference Number |
| BEST | BEST for adolescent BPD (Brief Education Supported Treatment for adolescent Borderline Personality Disorder): a feasibility study of delivery of specialised early intervention for borderline personality disorder through collaboration with education providers, incorporating a feasibility randomised controlled trial'. | 250938 |
| TRACC | The demenTia Research And Care Clinic (TRACC) | 205788 |
| iCARE wp1 | Towards Integrated support: The role of carer- and patient-level characteristics on family CARER quality of life at different stages of dementia (iCARE) | 225765 |
Research Studies (Either recruiting new participants or in follow-up) for which NSFT is not the Research Sponsor/Data Controller but where NSFT Data is being directly or indirectly processed and shared for Research Purposes can be found below.
To find out more about how your Data is being used in these studies, please contact the relevant Organisation listed in the below documents.
Non-NSFT Sponsored Research Studies (Aug 2020)
List of Educational Studies (Aug 2019)
NSFT Research policies
At NSFT Research, we have developed the following policies about setting up and conducting clinical research in the Trust.
Policies are in PDF format, and contain templates for use by researchers. Editable version of templates are also available from
rdofficemailbox@nsft.nhs.uk. Further guidance about conducting research in practice is available on the Researcher section of the website.
|
SOP # |
Short Title |
Date Approved |
Published |
Download |
| R&D001 |
Confirming research Capacity and Capability |
24/11/2016 |
01/01/2017 |
RD001 |
| R&D003 |
Research Integrity, Fraud and Misconduct |
29/06/2017 |
01/07/2017 |
RD003 |
| R&D005 |
Conducting Clinical Trials of Investigational Medicinal Products |
26/06/2017 |
01/07/2017 |
RD005 |
| R&D008 |
Research Trial Management: Trial Master Files and Site-Specific Files |
27/04/2017 |
01/05/2017 |
RD008 |
| R&D009 |
Research Auditing and Monitoring Procedures |
27/04/2017 |
01/05/2017 |
RD009 |
| R&D012 |
Gaining Valid Informed Consent from Participants for the Purpose of Research Studies |
28/06/2018 |
01/07/18 |
RD012 |
| R&D013 |
Research Study Close-down and Archiving Procedures |
28/06/2018 |
28/06/2018 |
RD013 |
| R&D016 v2.2 |
Research Adverse Event and Safety Reporting Procedures
|
28/06/2018 |
01/07/2018 |
RD016
Guidance:
SAEguidance
SAE Form:
SAEform
|
| R&D029 |
Income Distribution from NIHR Adopted Industry Sponsored Studies |
27/10/2016 |
01/11/2016 |
RD029 |
NSFT Research Operating Capability Statement
NSFT Research has an R&D Operational Capability Statement, endorsed by the Trust Board of Directors, which outlines our organisational capacity to undertake research:
NIHR B01 RnD Ops Capability May 2011
NIHR PID Reporting Data
The Government wishes to see a dramatic and sustained improvement in the performance of providers of NHS services in initiating and delivering clinical trials. In 2013 the NIHR requested that providers of NHS services publish outcomes of clinical trial research against certain benchmarks. From October 2014, the NIHR funding to providers of NHS services became conditional on the reporting of and meeting the two benchmarks of:
- Recruiting the first patient within the 70 day time period from submission of the study
- Delivery against the recruitment target agreed for the NSFT site.
The performance below reflects studies which are considered to be interventional or clinical trials only.
Performance in Initiating: Clinical Trials
Performance in Initiating Q2 2019-2020
Performance in Initiating Q3 2019-2020
Performance in Delivering: Commercial Studies
Performance in Delivering Q2 2019-2020
Performance in Delivering Q3 2019-2020
Previous PID Reports
National Research Guidance, Frameworks and Policies [Links to non-NSFT Controlled External Websites]
European directive for Clinical Trial Regulations:
UK Clinical Trial Regulations
An Introduction to the UK Clinical Trial regulations
UK legislation
UK Policy Framework for Health and Social Care Research
Approving research under MCA section 34
MRC ethics guides
Children
Informed Consent for Adults lacking capacity
